．Collect and prepare documents for regulatory and ethics committee/IRB submissions. ．Communicate with investigators to obtain necessary documentation and information throughout the clinical trial on an ongoing basis, to meet the quality and regulatory requirements of the company/site/regulatory authority. ．Assist in clinical trial execution, such as explain inform consent forms, fill in case report form, etc. ．Overall responsible to ensure appropriate project files are set up and maintained accurately and in a timely manner, to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements.

Collect and organize clinical data from electronic medical records and questionnaires in an accurate manner, and analyze epidemiology survey and clinical data statistically. Manage principal investigator-initiated human studies, responsible for more than 10 IRB projects, which include new project, mid-term report, amendment and final report. Explain study procedure to subjects in studies and follow up subjects regularly. Qualified to ensure consistency of operational aspects of running studies. Caliway Biopharmaceuticals Co., Ltd Taipei, Taiwan

Review and organize research literature in a detailed and scientific manner. Prepare SOPs for study endpoint measurements. Responsible for purchase requisition and order of the department. Handle multiple tasks with conflicting timelines and project management. Taipei Veterans General Hospital Taipei, Taiwan

Prepare experimental materials. Ensure the lists of clinical samples well documented.